Cleared Traditional

K850403 - MEC DISTAL FEMORAL BOLT

K850403 is an FDA 510(k) clearance for MEC DISTAL FEMORAL BOLT, manufactured by Pfizer, Inc.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K850403 · Pfizer, Inc. · Orthopedic device
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Jul 1985
Decision
164d
Days
Class 2
Risk

K850403 is an FDA 510(k) clearance for the MEC DISTAL FEMORAL BOLT. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Pfizer, Inc. (Ny, US). The FDA issued a Cleared decision on July 15, 1985 after a review of 164 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Pfizer, Inc. devices

FDA 510(k) Submission Details - K850403

510(k) Number K850403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1985
Decision Date July 15, 1985
Days to Decision 164 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 122d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTT Device Classification - Class 2, Special Controls

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 353
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K850403.
SCREW DRIVER/BONE SCREW WRENCH/TAP & GUIDE PIN
K862311 · Warsaw Orthopedic, Inc. · Jul 1986
DEPUY COMPRESSION HIP SCREW SYSTEM
K861178 · Depuy, Inc. · Apr 1986
KIRSCHNER COMPRESSION HIP SCREW SYSTEM
K854205 · Kirschner Medical Corp. · Nov 1985
MEC HIP BOLT
K850413 · Pfizer, Inc. · Jul 1985
MEC ROD CONNECTOR
K850443 · Pfizer, Inc. · Jul 1985
SUPRACONDYLAR BONE PLATE
K851919 · Warsaw Orthopedic, Inc. · Jun 1985